Kornimate/medical-research-clean huggingface dataset:
a prospective multicenter non-interventional study of women treated with esmya (ulipristal acetate) as pre-operative treatment of moderate to severe symptoms of uterine fibroids

Conditions: Uterine Fibroids

Summary: this is a multi-center, prospective, non-interventional study of patients who have been diagnosed with moderate to severe symptoms of uterine fibroids and are initiating a pre-operative treatment with esmya. the objectives of the study are to characterize and describe treatment with esmya and to evaluate the safety, effectiveness, and hrql outcomes in this population


Eligibility criteria:
inclusion criteria: - pre-menopausal adult women with a diagnosis of moderate or severe symptoms of uterine fibroids who are initiating treatment with esmya. exclusion criteria: * patient is pregnant or plans to become pregnant in the next 3 months, * patient is breastfeeding, * patient has genital bleeding of unknown etiology or not due to uterine fibroids, * patient has been diagnosed with uterine, cervical, ovarian or breast cancer, * patient is using an investigational drug/therapy or has discontinued the use of an investigational drug/therapy within 30 days prior to study enrollment, * patient has hypersensitivity to the active substance of esmya or to one of its excipients
use of mri and pet for assessing disease activity in takayasu's arteritis

Conditions: Takayasu Arteritis

Summary: assessing disease activity in people with takayasu's arteritis is difficult, as most people with the disease do not exhibit visible, measurable symptoms. combination positron emission tomography/computed axial tomography (pet/ct) is a particularly sensitive, accurate scanning method that may improve researchers' ability to evaluate people with the disease. this study will determine the effectiveness of pet/ct in assessing disease activity in people with takayasu's arteritis.

takayasu's arteritis is a rare inflammatory disease that affects the aorta and its branches. the disease is much more common in females than in males, and disease onset typically occurs between the ages of 15 and 30. people with this disease often experience general discomfort, fatigue, fever, night sweats, weight loss, and joint pain. in the late stages of the disease, weak arterial walls may lead to aneurysms. many patients do not exhibit any visible symptoms until this point, however. because many people with takayasu's arteritis do not have overt disease symptoms, the assessment of disease activity is difficult. laboratory tests can help, but are often unreliable. novel approaches to assessing disease activity are urgently needed to enhance and facilitate research on takayasu's arteritis. this study will determine the effectiveness of combination positron emission tomography/computed axial tomography (pet/ct) in assessing disease activity in people with takayasu's arteritis. participants in this study will enroll while their disease is active. the first pet/ct scan will take place upon study entry, while there is active disease. participants will have a second pet/ct scan 3 months later, and a third scan 3 months after that if there is still active disease present. participants will have a maximum of 3 scans unless a scan needs to be repeated because of technical failures, though this does not often happen. if there is no active disease at the time of the second scan, a third scan will not be done. all pet/ct scans will be scheduled within 10 days of participants' routine mri scans. this study will not require any follow-up visits.

Eligibility criteria:
inclusion criteria: * diagnosis of takayasu's arteritis, as defined by the vcrc longitudinal study #5503 * currently enrolled in the vcrc longitudinal study #5503 * active disease has occurred in conjunction with a disease relapse within 2 weeks before study entry (a detailed definition of "active disease" is available in the study protocol.) * willing and able to comply with the schedule for imaging studies and follow-up procedures exclusion criteria: * pregnant or breastfeeding * unable to comply with study guidelines * unable to safely undergo mri scanning

Keywords: large-vessel vasculitis
bone status and insulin resistance in hirsutism

Conditions: Hirsutism

Summary: the purpose of this study is to investigate how the bones of hirsute women are different from bones of healthy women. the change in hormone content in the blood will also be investigated. the study can be used to evaluate whether it will be relevant to bone scan all newly referred hirsute women. hirsute women are often over-weight and often have an increased amount of the male sex hormone in their blood. their blood tests often show changes reminding of the ones seen in diabetic patients. all hirsute women referred to the department will undergo an investigation revealing the reason for the increased hair growth. the investigation includes clinical investigation (height, weight and degree of hair growth), blood tests (for hormone status and bone status analysis) and bone scanning of the abdomen (body composition). the trial includes a group of 50 strongly hairy women and a control group of 50 healthy women with normal hair growth. they are matched by body weight, since weight has great importance for the bone mineral content and thereby for osteoporosis in the long run.


Eligibility criteria:
inclusion criteria: hirsute subjects: * belonging to group 1 or 2. * age: 20-46 * hirsute score: \>7 * written informed consent control group: * age: 20-46 * hirsute score: 0 (without razing) * regular menses * written informed consent exclusion criteria: * previous cosmetic treatment for hirsutism. * use of contraceptive pill (within the past 6 months) * systemic steroid treatment \> 6 weeks (ever) * age above 46 years/post menopause (increased fsh) * recognized diabetes mellitus or other endocrine disease * eating disorder * serious, treatment demanding disease

Keywords: hirsutism bone status androgens insulin
effects of transcranial direct current stimulation (tdcs) and transcranial ultrasound on osteoarthritis pain of the knee

Conditions: Chronic Pain; Osteoarthritis

Summary: the purpose of this study is to see the effects of transcranial direct current stimulation (tdcs) on the pain associated with osteoarthritis of the knee. the investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation. before, during and after stimulation, the investigators will measure and assess changes intracranial blood flow with transcranial ultrasound.


Eligibility criteria:
study eligibility criteria inclusion criteria: 1. providing informed consent to participate in the study 2. 18 to 64 years old 3. having chronic osteoarthritis knee pain in either knee (existing pain for more than 6 months with an average of at least 3 on a 0-10 vas scale) 4. pain resistant to common analgesics and medications for chronic pain such as tylenol, aspirin, ibuprofen, soma, parafon forte dcs, zanaflex, and codeine. 5. must have the ability to feel pain as self reported exclusion criteria: 1. subject is pregnant. 2. contraindications to tdcs: * metal in the head * implanted brain medical devices 3. contraindications to tus: * metal in the head * implanted brain medical devices 4. history of alcohol or drug abuse within the past 6 months as self reported 5. use of carbamazepine within the past 6 months as self reported. 6. suffering from severe depression (with a score of \>30 in the beck depression inventory) 7. history of neurological disorders as self reported. 8. history of unexplained fainting spells as self reported, 9. history of head injury resulting in more than a momentary loss of consciousness as self reported 10. history of neurosurgery as self reported

Keywords: transcranial direct current stimulation transcranial ultrasound
synergistic immunomodulatory effect of synbiotics pre and postoperative resection of pancreatic ductal adenocarcinoma

Conditions: Pancreatic Ductal Adenocarcinoma

Summary: the goal of this interventional study was to evaluate the synergistic effect of symbiotics (a combination of probiotics and prebiotics) compared to probiotics alone in terms of their impact on anti-tumor immunomodulation in patients with pancreatic ductal adenocarcinoma (pdac). the study also aimed to assess the effects of these interventions on postoperative complications and outcomes. in the study, a probiotic agent (nowfoods, usa), containing ten strains of bacteria with a total dosage of 25 billion colony-forming units (cfu) was administered. this probiotic regimen involved taking two capsules once daily, starting two weeks before the surgery and continuing for one month after the surgery. for the synbiotic group, in addition to the probiotic agent, two capsules per day of inulin supplement (herbamama, usa) were also taken. the study included three groups: the synbiotics group, the probiotics group, and the placebo group. the researchers compared the pathological status of immune cell infiltration (specifically cd8 cells) and interferon-gamma expression, as well as the levels of interleukins 10, 6, and 10 in the participants' serum. four blood samples were collected from each participant: one taken 14 days before the surgery, one on the surgery date, one two weeks after the surgery, and one 30 days after the surgery. the main research question addressed by the study was whether there was a significant difference in the immunomodulatory effect and postoperative complications between the synbiotics group and the probiotics group. the placebo group likely served as a control to compare the effects of the interventions against no intervention.


Eligibility criteria:
inclusion criteria: * patients with primary pdac with complete pathological and follow-up data * patients without long-distance metastasis * patients without chronic diseases * patients without any treatments before the surgery. exclusion criteria: * patients who suffered from other tumors or other chronic diseases or accidentally died * lack of pathological and follow-up data. * patients with long-distance metastasis before the surgery.
noninvasive surrogate marker for advanced hepatocellular carcinoma response to concurrent chemoradiotherapy: mr perfusion, contrast enhanced ultrasound and biomarkers

Conditions: Advanced Adult Hepatocellular Carcinoma

Summary: hepatocellular carcinoma is the sixth most common malignancy and the third most common cause of cancer-related death worldwide. the incidence of hcc is rising in europe and the united states and is expected to continue to increase during the next 2 to 3 decades. the expected survival rate is still decimal, especially in patients with advanced hcc. however, in recent years, several treatment methods for patients with advanced hcc, including antiangiogenic chemotherapy, radiotherapy, concurrent chemoradiotherapy, and dc bead transarterial chemoembolization, have been developed. among these new treatment methods, concurrent chemoradiotherapy has also proved to increase patient's survival rate. it is important to predict treatment response before treatment or immediately after treatment because there are several other treatment options as mentioned above. recently, there have been several reports that mr perfusion parameters such as ktrans can predict treatment response in cervical cancer and colorectal cancer. therefore the purpose of the investigators study is to evaluate the feasibility of predicting treatment response by mr perfusion, contrast enhanced ultrasound parameters and biomarkers (il-6, il-12 and vegf) in patients with advanced hepatocellular carcinoma who undertake concurrent chemoradiotherapy.


Eligibility criteria:
inclusion criteria: * patients who have advanced hepatocellular carcinoma and plan to undertake concurrent chemoradiotherapy. * patients willing to undergo the study procedure * patients who are fully informed about the study and have signed the informed consent form exclusion criteria: * patients (men or women) under 20 years of age * patients who have been received any other treatment including tace, operation, taci, systemic chemotherapy, intraarterial chemotherapy, antiangiogenic therapy * patients who have hypersensitivity to mr or us contrast agents * women who are pregnant, lactating or who are of childbearing potential and have not had a negative pregnancy test at baseline visit * patients not eligible to contrast media injection according to product labeling * patients with a contraindication for mri or ct * patients with impaired renal function (e.g. acute renal failure) or patients on dialysis
evaluation of fidaxomicin in the treatment of clostridium difficile infection (cdi)

Conditions: Clostridium Difficile Infection (CDI)

Summary: this is a single center collection of discarded biological samples and electronic medical review (emr) data on patients who are hospitalized with clostridium difficile infections and treated with fidaxomicin

this single site study will be a clinical research data base of patients hospitalized and diagnosed with clostridium difficile infection (cdi), treated with fidaxomicin and willing to allow us to collect discard biological samples for testing and analysis in the investigators lab. an additional blood sample will be obtained if a clinically indicated bronchoscopy is performed as to measure the amount of medication in the bal. we will also complete a medical record review will also occur.

Eligibility criteria:
inclusion criteria: 1. ≥18 years of age 2. currently an inpatient at upmc presbyterian 3. diagnosed with an cdi 4. being treated with fidaxomicin exclusion criteria: not meeting entry criteria
safety and efficacy of treatment with interferon beta-1a rebif® in patients with crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of this study is to determine the safety and efficacy of interferon beta-1a in maintaining remission in patients with crohn's disease.


Eligibility criteria:
inclusion criteria: * patients with an established diagnosis of crohn's disease who went into remission using corticosteroids within 4 weeks before the study exclusion criteria: * any other treatment for the maintenance of remission of crohn's disease
french adaptation of the california card sorting task (ccst) in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: cognitive impairment affects up to 65% of multiple sclerosis (ms) subjects, especially executive functions. the california card sorting task (ccst) assesses specific components of problem-solving ability. there is currently no french version of this test. reims neurological department in collaboration with rothschild foundation has developed a french adaptation of ccst. this version includes three cards packages with two alternate forms to control practice effects (test-retest). in order to assess "test-retest reliability" we have to verify the comparability of the three cards packages within one session in ms patients.


Eligibility criteria:
inclusion criteria: * multiple sclerosis patients * age \> 18 years old exclusion criteria: * montreal cognitive assessment (moca) ≤20 * psychiatric disease * no proficiency in the french language * opposition to participate in the study * no medical insurance coverage
tarceva. icorg 08-41

Conditions: Non-small Cell Lung Cancer

Summary: the aim of this study is to determine prospectively the value of a recently identified proteomic signature in identifying those patients with lung cancer, who are likely to benefit from and respond favourably to erlotinib therapy. this is a prospective study of serum proteomics as a predictor of response to erlotinib therapy.

screening/baseline 1. routine blood tests (haematology and biochemistry) as per hospital practice 2. research serum sample for proteomic studies (10ml blood sample) 3. routine pre-treatment ct but with formal recist/who measurements of tumour size 2 months post commencement of treatment with erlotinib: routine ct with recist/who assessment 4 months post commencement of treatment with erlotinib: routine ct with recist/who assessment 1 year post commencement of treatment with erlotinib (as per current standard of care): routine ct with recist/who assessment response assessment: ct scans at baseline, at 2 and 4 months post commencement of therapy and one year after treatment with erlotinib will be analyzed with the emphasis on identification of disease progression. follow up: subsequent follow-up as per routine.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * any patient who is suited to receive ct scans as part of his/her routine care * ability to understand and the willingness to sign a written informed consent, given according to ich/gcp, and national/local regulations. a signed informed consent must be obtained prior to any study specific procedures * planned treatment with erlotinib. exclusion criteria: * patients younger than 18 years of age * patients not foreseen to receive tarcevatm treatment

Keywords: non-small cell lung cancer erlotinib tarcevatm proteomic signature
comparing the impact of cancer on quality of life between survivors of childhood solid tumors and leukemia

Conditions: Childhood Solid Tumor

Summary: the aim of the study is to examine the impact of cancer and treatment-related effects on the physical and psychosocial well-being and quality of life among hong kong chinese survivors of childhood solid tumors.

in general, cancer can be divided into two main categories: blood cancer and solid tumors. leukemia refer to the cancers in blood while solid tumors refer to the cancers which involve the formation of an abnormal mass without any liquid or cysts. patients suffer from leukemia are usually have better prognosis which result in better psychological well-being when compared with those suffer from solid tumors (rodin et al., 2010). the development of solid tumors in children is different from that in adult. some of the solid tumors such as osteosarcoma, neuroblastoma, rhabdomyosarcoma, wilms' tumor and retinoblastoma are exclusively found in children. other types of solid tumors such as brain tumor can also be found in children. yet, most of recent studies in hong kong have focused in general childhood cancer survivors or their family members but no study has been conducted to focus on the physical and psychological well-being of survivors of childhood solid tumors (li, lopez, chung, ho, \& chiu, 2013; wills, 2009). therefore, the quality of life and psychological well-being of solid tumors survivors are always be overestimated. the actual psychological needs of solid tumors survivors may be overlooked. there is thus an imperative need to investigate the impact of cancer and treatment-related effects on the physical and psychosocial well-being and quality of life among hong kong chinese survivors of childhood solid tumors.

Eligibility criteria:
inclusion criteria: * (1) hong kong chinese under the age of 30 years at the time of study participation; * (2) diagnosed with solid tumors or hematological malignancies under the age of 19 years; * (3) completed the entire course of treatment for at least 6 months; * (4) able to speak fluent cantonese and read chinese. exclusion criteria: * survivors with secondary malignancy, organic cause psychosis, cognitive or learning problems, or under active cancer treatment will be excluded from this study.
study of hemodynamics of neonates by echocardiography and uscom

Conditions: Sepsis; Congenital Heart Disease

Summary: the purpose of this study is to evaluate the hemodynamic values of neonates that are healthy and those with various congenital heart diseases and sepsis by using echocardiography and uscom.

echocardiography is a diagnostic tool for congenital heart disease.however,it requires skilled specialists to perform it and is a little expensive.besides,it is too big to move to the bedside easily.uscom is another newly choice to evaluate hemodynamic values in recent years.this study will compare the hemodynamic values of neonates that are healthy and those with congenital heart diseases and sepsis by using echocardiography and uscom.

Eligibility criteria:
inclusion criteria: * neonatal * congenital heart disease * sepsis exclusion criteria: * aged more than thirty days

Keywords: hemodynamics neonatal
treatment of marijuana withdrawal syndrome using escitalopram and cognitive-behavior therapy

Conditions: Marijuana Dependence

Summary: recent studies have established the reliability, validity and time course of the cannabis withdrawal syndrome. this study will investigate the effects of combined treatment of escitalopram with cognitive-behavior therapy in alleviating the symptoms of the marijuana withdrawal syndrome in regular chronic users of marijuana. we predict that combined pharmacological treatment and cognitive-behavior therapy will help patients to abstain from using using marijuana and it will alleviate their marijuana withdrawal symptoms.

recent studies have established the reliability, validity and time course of the cannabis withdrawal syndrome characterized by symptoms of anxiety, irritability, negative mood, physical symptoms and decreased appetite. this study will investigate the effects of combined treatment of escitalopram with cognitive-behavior therapy in alleviating the symptoms of the marijuana withdrawal syndrome in regular chronic users of marijuana. 40 patients will be blindly randomized to either active or placebo escitalopram 10mg/day, for 12 weeks followed bt 12 weeks of follow-up. inclusion criteria include: * men and women age 20-45 * dsm-iv diagnosis of thc dependence. exclusion criteria include: * dependence on other drugs or alcohol * bipolar disorder or schizophrenia, major depression, suicidal ideation psychotic symptoms or violent thoughts * current treatment with anti-depressant medication * neurological disease * physical illness (hypothyroidism, severe anemia, renal failure) * past severe effects of ssris. outcome measures include: * urine thc analysis every two weeks * questionnaires assessing addiction severity index * depression and anxiety.

Eligibility criteria:
inclusion criteria: * men and women aged 20-45 * dsm iv criteria of marijuana dependence. exclusion criteria: * other drug or alcohol dependence * bipolar disorder, schizophrenia, major depression, suicidal ideation, psychotic symptoms or violent thoughts * physical illness including hypothyroidism, neurological disease, severe anemia, and renal failure * past severe side effects of ssris.

Keywords: marijuana dependence withdrawal escitalopram